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Report for Clinical Trial NCT03599206

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.

NCT03599206 Environmental and Genetic Factors on Lung Function

2 Interventions

Name: Ozone

Description: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).

Type: Drug

Ozone

Name: Filtered Air

Description: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.

Type: Other

Filtered Air


Primary Outcomes

Description: This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL. Each value will be compared to the individuals filtered air control and reported as a fold change from baseline. These are independent values but are both accepted in the literature as measures of epithelial permeability.

Measure: Change in Ozone (O3) induced epithelial permeability, as measured by the level of clara cell secretory protein (ng/mL)

Time: Baseline, 21 days

Description: This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The bronchoalveolar lavage will be similarly used to define the albumin level. Albumin is also measured by ELISA. The value is reported at ug/mL. Each value will be compared to the individuals filtered air control and reported as a fold change from baseline. These are independent values but are both accepted in the literature as measures of epithelial permeability.

Measure: Change in Ozone (O3) induced epithelial permeability, as measured by albumin level (ug/mL)

Time: Baseline, 21 days

Secondary Outcomes

Description: Measured by real-time PCR

Measure: Change in Ozone O3 induced alterations in gene expression of airway epithelial cells, and bronchoalveolar lavage cells

Time: Baseline, 21 days

Description: Measured by multiplex ELISA

Measure: Change in Ozone O3 induced alterations in bronchoalveolar lavage cytokines and growth factors

Time: Baseline, 21 days

Purpose: Other

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 rs2280964

Inclusion Criteria: - Prior enrollment in the NIEHS Environmental Polymorphism Registry located in the greater Raleigh-Durham area - Wild type or homozygous (female)/hemizygous (male - since sex-linked) expression of the CXCR3 polymorphism rs2280964 Exclusion Criteria: - Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years - BMI > 35 kg/m2 - Pregnant women and women who are presently lactating.



HPO Nodes